Intravascular devices, such as guide wires, catheters, guide catheters, etc., can be configured for imaging, flow measurement, pressure measurement, and/or providing therapy, among other functions. Such intravascular devices are generally disposable devices. Further, a manufacturer generally rates the intravascular device for a single use. The intravascular devices can be required to be sterile and/or have consistent performance at or near the limits of material properties, such as the plastic-elastic limit. Thus, the manufacturer can guarantee the safety of the intravascular device and/or the integrity of the data collected using the intravascular device only for a single use. After being used within the vasculature of a patient in a clinical procedure, the intravascular device is discarded.
Recently, third parties who do not have support from the original equipment manufacturer have collected used intravascular devices. The used intravascular devices are then sterilized, repackaged, and sold for future use in clinical procedures. The third parties can lack the manufacturer's understanding of the design, tolerances, limitations, verification and validation data, manufacturing process controls, calibrations, and other aspects of the intravascular devices. Accordingly, there are significant risks to patients when unauthorized intravascular devices are used. This is true even if sterility, bio-burden, and biocompatibility are validated according to established standards and regulations. The intravascular devices cannot be guaranteed or expected to meet the efficacy standards of an authentic intravascular device from the manufacturer. When an intravascular device is incorrectly reprocessed or reused, patients can be exposed to direct harm via contamination. It can also expose patients to the possibility of misdiagnosis when a disposable intravascular device is used for a longer time than it was designed to operate safely. In addition to patient safety concerns, a manufacturer also suffers financial losses when customers purchase repackaged, used intravascular devices as opposed to authorized ones.
Some efforts have been made previously to ensure that only authorized intravascular devices are used in clinical procedures. Disposable intravascular devices are connected to a reusable computing device in the procedure room before they are used. The computing device can conduct one or more checks to verify the authenticity of the intravascular device. When the intravascular device's on-board data does not pass the check, the computing device can cease operating or can disallow use of the intravascular device. Conventionally, the computing device must access to the intravascular device data in order for the check to be conducted. Thus, if a computing device has not been programmed to conduct the check before being deployed in a clinical environment, the computing device may be unable to verify the authenticity of intravascular devices.
Thus, there remains a need for an authentication system that comprehensively prevents the use of unauthorized, fraudulent, and/or otherwise tampered-with intravascular devices.